Indication

Neupro® (Rotigotine Transdermal System) is a patch that is used to treat the signs and symptoms of idiopathic Parkinson’s disease and moderate-to-severe primary Restless Legs Syndrome (RLS).

IMPORTANT SAFETY INFORMATION

NEUPRO contains a sulfite called sodium metabisulfite. Sulfites can cause severe allergic reactions that are life threatening to some people who are sensitive to sulfites. People with asthma are more sensitive to sulfites. Remove the patch right away and call your doctor if you have swelling of the lips or tongue, chest pain, or trouble breathing or swallowing.

NEUPRO may make you fall asleep suddenly or without warning while doing normal activities, such as driving, which may result in accidents. Tell your doctor right away if this happens. Drinking alcohol or taking other medicines that cause drowsiness may increase your chances of becoming sleepy while using NEUPRO. Do not drive, use hazardous machinery, or do other dangerous activities until you know how NEUPRO affects you.

NEUPRO can cause or worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. The chances of having hallucinations or these other psychotic-like changes are higher in people with Parkinson’s disease who are elderly, taking NEUPRO, or taking higher doses of NEUPRO. If you have any of these problems, talk to your doctor.

NEUPRO can cause decreases in blood pressure, especially when you start or increase your dose. Increases in blood pressure and heart rate, fainting, weight gain, and fluid retention also can occur. If you faint or feel dizzy, nauseated, or sweaty when you stand up from sitting or lying down, or have an unusually fast increase in weight, swelling, or fluid retention, especially in the ankles or legs, tell your doctor.

Some patients using NEUPRO get urges to behave in a way that is unusual for them, such as unusual urges to gamble or increased sexual urges and behaviors. If you or your family notices you are developing any unusual behaviors, talk to your doctor.

NEUPRO may cause uncontrolled sudden movements or make such movements you already have worse or more frequent if you have Parkinson’s disease, which may mean that your anti-Parkinson’s medicine needs to be changed. NEUPRO also may cause Restless Legs Syndrome symptoms to come back (rebound), become worse, or start earlier in the day.

Skin reactions may occur at the site where you apply NEUPRO. Tell your doctor if you get a rash, redness, swelling, or itching that will not go away. Some people with Parkinson’s disease may have an increased chance of getting a skin cancer called melanoma. You should have your skin checked by a doctor regularly.

Avoid exposing the NEUPRO patch you are wearing to heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and direct sunlight. Too much medicine could be absorbed into your body. Also, do not wear NEUPRO during medical procedures called magnetic resonance imaging (MRI) or cardioversion because this could cause skin burns.

Tell your doctor if you have breathing problems, a sleep disorder, mental problems, high or low blood pressure, or heart problems; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. NEUPRO may not be right for you.

The most common side effects in people taking NEUPRO for Parkinson’s disease are nausea, vomiting, sleepiness, application site reactions, dizziness, loss of appetite, increased sweating, difficulty sleeping, leg swelling, and uncontrolled, sudden movements of the arms or legs. The most common side effects in people taking NEUPRO for Restless Legs Syndrome are application site reactions, nausea, sleepiness, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see additional Patient Information about the NEUPRO Patch. This information does not take the place of talking with your healthcare provider about your condition or your treatment.